Regulatory Affairs Manager jobs in Salem, OR

Position Overview

In The Research department is critical to this mission because we offer patients access to novel therapies and opportunities that are unavailable outside of a clinical trial. We ensure that our trial opportunities support the cancer needs of our community and continue to grow our team with high skilled, compassionate research team members in our premier research program.

The Research Coordinator and Regulatory Associate is key to the Research team in supporting for our clinical trial patients by screening for eligible patients to enroll in clinical trials, coordinating research activities per protocol and as delegated by the Research Nurse(s) and Director of Research. In addition, a important function of this role is to support compliance with the regulatory requirements to meet local and federal guidelines, regulations, and laws and engaging the Research team and the Principal Investigator in meeting rigorous standards. Approximately half of the time will be spent as a Research Coordinator and the other half spent as a Regulatory Associate.

Essential Job Functions

• Identifies potentially eligible study participants in collaboration with attending physician and/ or treating provider
• Completes study visits in compliance with respective protocol schedule of activities
• Provides accurate and timely data collection, documentation, entry, reporting in EDC and CTM, and in the EMR per protocol requirements
• Communicates and collaborates with study team, including internal and external parties, sponsors, CRO, PI and study participants
• Assists with study startup and closeout activities, including archiving procedures
• Prepares, reviews, and submits regulatory documents/ logs efficiently while following sponsor instructions for completion
• Organizes, maintains, and ensures completeness for both physical and electronic Investigator Site File (ISF) in real-time in collaboration with the Research Nurses and/or Clinical Research Coordinators.
• Maintains a system to ensure regulatory certificates (i.e., GCP, HSP, IATA, Equipment calibrations, CLIA, CAP certificates)remain current and accessible
• Conducts regular quality control checks including applying audit tool(s) and assists with internal and external audits and monitor visits

Required Qualifications

• Associate degree, certification in research (to be obtained within 12 months of hire/ internal transfer), or relevant coursework completed
• GCP/HSP certification
• Minimum of 1 year experience in research
• Knowledge of basic research protocols and procedures
• Superior customer service, communication and organizational skills
• Ability to prioritize and ensure project completion on time
• Attention to details

Preferred Qualifications

• Strong analytical skills
• ACRP or SOCRA Certified
• Working knowledge of local and federal rules and regulations
• Experience working with complex clinical trials/ clinical research program

Would you thrive in this position?

• Are you detailed oriented?
• Can you develop workflows, processes and procedures to support regulatory compliance?
• Are you able to foster relationships with the Research team, sponsors, sponsor representative and across the organization?
• Can you engage in learning opportunities to ensure alignment with governing rules and regulations to maintain excellent study conduct?
• Do you maintain integrity and confidentiality?
• Do you understand how clinical research is an integral part of the medical industry?